Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

Sarcoma Clinical Trial

Official title:

Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003008
• Other study ID #: CDR0000065583
• Secondary ID: E1D95AMC-014
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 1997

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.

Description:

OBJECTIVES:

• Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate).

OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no), prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no).

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients who previously received paclitaxel receive no more than 1 course during this study.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed Kaposi's sarcoma requiring chemotherapy and/or currently being treated with paclitaxel

• Serologic diagnosis of HIV infection documented by a positive ELISA and confirmed with a Western Blot or other federally approved HIV diagnostic test

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm ^3(with or without the use of colony-stimulating factors)

• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Neurologic:

• No greater than grade 2 peripheral neuropathy

• No neuropsychiatric history or altered mental status that would preclude study

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

• No sensitivity to E. coli-derived proteins

• No active untreated infection

• No new infectious complications requiring a change in antibiotics within the past 2 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 week since prior radiotherapy

• No prior radiotherapy to marker lesions

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 2 weeks since prior systemic treatment for Kaposi's sarcoma

• At least 2 weeks since prior nonapproved FDA investigational agents except available Investigational New Drugs that are antiretroviral agents

• Concurrent maintenance therapy for opportunistic infections allowed

• Concurrent commercially available antiretroviral therapy allowed

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• indinavir sulfate

• nelfinavir mesylate

• paclitaxel

• ritonavir

• saquinavir mesylate

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	AIDS Associated Malignancies Clinical Trials Consortium, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,